| CTRI Number |
CTRI/2024/12/077761 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare how well Brahmi Ghana Vati and Alprazolam work in reducing anxiety before surgery. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Brahmi (Bacopa monniera) Ghana Vati with Alprazolam as an Anxiolytic in Preanesthetic Management. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjali Kolte |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri |
| Address |
Department of Shalya tantra,
Dr. D. Y. Patil College of Ayurved and Research Centre, Sant tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8698837633 |
| Fax |
|
| Email |
anjalikolte166@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay C Babar |
| Designation |
M.S. (Shalyatantra) Ph.D. Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri |
| Address |
Department of Shalya Tantra,
Dr D Y Patil College of Ayueved and Research Centre, Sant tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay C Babar |
| Designation |
M.S. (Shalyatantra) Ph.D. Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri |
| Address |
Department of Shalya Tantra,
Dr D Y Patil College of Ayueved and Research Centre, Sant tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Ayurved and Research Centre, Sant tukaram Nagar, Pimpri, Pune, Maharashtra, India, 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Anjali Kolte |
| Address |
Dr D Y Patil College of Ayurved and Research Centre, Sant tukaram Nagar, Pimpri, Pune, Maharashtra, Indian - 411018 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjali Kolte |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune |
Department of Shalya Tantra, OPD no. 3 and Shalyatantra IPD.
Pune
MAHARASHTRA |
8698837633
anjalikolte166@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. DYPCA and RC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F408||Other phobic anxiety disorders. Ayurveda Condition: MANOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Brahmi Ghana Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Alprazolam | Tab. Alprazom 0.25 mg HS will be given to patient on night prior to surgery. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are undergoing elective surgery and are admitted atleast one day before the
scheduled surgical procedure. |
|
| ExclusionCriteria |
| Details |
1. Patients with known cases of neurological diseases.
2. Patients on anti-depressants or anti-psychotic drugs. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the role of Bramhi Ghana Vati as anxiolytic in pre-anaesthetic management. |
Assessment will be done on following interval
1. On previous night of surgery
2. 12 hours after administration of drug
3. Just before the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study adverse effects if any |
First dose of Brahmi Ghana Vati will be given to patient on previous night of surgery and assessment will be done on following interval
1. On previous night of surgery
2. 12 hours after administration of drug
3. Just before the surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Brahmi (Bacopa monnieri) Ghana Vati with Alprazolam as an Anxiolytic in Preanesthetic Management. 70 patients with pre-operative anxiety will be treated by Brahmi Ghana Vati and Tablet Alprazolam on the previous night of surgery. Follow-up of the patient will be taken 12 hours after the administration of the medicine and just before the surgery. |